A First In Human (FIH) Study of IBI356 in Healthy Participants and in Atopic Dermatitis Patients

Phase 1

Active, not recruiting

• Conditions: Healthy Participants; Atopic Dermatitis Patients
• Interventions: Drug: Placebo for MAD; Drug: Dupilumab for MAD; Drug: Placebo for SAD; Drug: IBI356 for SAD; Drug: IBI356 for MAD

• Registration Number: NCT06193434
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of IBI356 in Healthy Participants and in Atopic Dermatitis Patients

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-12
• Study First Submitted QC: 2023-12-21
• Study Start: 2024-01-05
• Study First Posted: 2024-01-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-14
• Primary Completion: 2025-08-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

1. Healthy participants:

   1. Aged 18 to 45 years,
   2. Weight 50 to 120 kgs,
   3. Good physical and mental health based on medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator.
   4. No child-bearing potential during the trial and within 6 months after SAD doses, and adequate contraceptive measures can be taken.

2. Atopic dermatitis:

   1. Aged 18 to 75 years,
   2. body mass index (BMI): 18.0 - 32.0 kg/m2,
   3. Atopic Dermatitis (AD) for 1 year or longer at Baseline,
   4. Eczema Area and Severity Index (EASI) of 16 or higher at baseline,
   5. Investigator Global Assessment (IGA) of 3 or 4 at baseline,
   6. AD involvement of 10 percent or more of body surface area at Baseline,
   7. Documented history, within 1 year before Baseline, of either inadequate response to topical treatments or inadvisability of topical treatments,
   8. Must have applied a stable dose of topical bland emollient at least twice daily for at least 7 consecutive days before Baseline.

Exclusion Criteria

1. History of relevant drug allergies.

2. Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments

3. Healthy participants:

   1. History of alcohol abuse or drug addiction within 1 year before screen,
   2. Positive drug and alcohol screen at screening.

4. Atopic dermatitis:

   1. Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, was likely to require Immunosuppressive/ immunomodulating drugs treatment(s) during the first 4 weeks of study treatment:
   2. Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week before the baseline visit.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo for MAD	Placebo for MAD	-
Dupilumab for MAD	Dupilumab for MAD	-
Placebo for SAD	Placebo for SAD	-
IBI356 for Single ascending dose (SAD)	IBI356 for SAD	-
IBI356 for Multiple ascending dose (MAD)	IBI356 for MAD	-

Primary Outcome Measures

Name	Time	Method
Occurrence of Adverse Event (AE) in SAD study.	Baseline to Week 20
Occurrence of Adverse Event (AE) in MAD study.	Baseline to Week 36
Changes in blood pressure mmHg (as a measure of safety and tolerability) in SAD study.	Baseline to Week 20
Changes in blood pressure mmHg (as a measure of safety and tolerability) in MAD study.	Baseline to Week 36
Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability) in SAD study.	Baseline to Week 20
Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability) in MAD study.	Baseline to Week 36
Changes in heart rate bpm (as a measure of safety and tolerability) in SAD study.	Baseline to Week 20
Changes in heart rate bpm (as a measure of safety and tolerability) in MAD study.	Baseline to Week 36
Changes in tympanic temperature °C in SAD study.	Baseline to Week 20
Changes in tympanic temperature °C in MAD study.	Baseline to Week 36
Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability) in SAD study.	Baseline to Week 20
Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability) in MAD study.	Baseline to Week 36
Occurrence of Serious Adverse Event (SAE) in SAD study.	Baseline to Week 20
Occurrence of Serious Adverse Event (SAE) in MAD study.	Baseline to Week 36

Secondary Outcome Measures

Name	Time	Method
Area under the concentration time curve from time 0 to last observation (AUC 0-t).	Baseline to Week 16
Maximum observed concentration (Cmax) after infusion.	Baseline to Week 16
Systemic clearance after infusion (CL).	Baseline to Week 16
Volume of distribution during the terminal phase after infusion(Apparent volume of distribution, V).	Baseline to Week 16
Elimination half-life during the terminal phase after infusion(Half-life, t1/2).	Baseline to Week 16
To assess immunogenicity: production of anti-drug antibodies (ADA) following SAD and Multiple ascending dose(MAD) doses.	Baseline to Week 16

Trial Locations

Locations (1)

Shanghai Skin Disease Hospital; 🇨🇳 Shanghai, Shanghai, China